NICE guidances: bad for GSK, good for Amgen and Novo

The National Institute for Health and Clinical Excellence has published final guidance rejecting the use of GlaxoSmithKline’s Revolade for the bleeding disorder ITP, but recommending Amgen’s Prolia for osteoporotic fracture prevention and Novo Nordisk’s Victoza for diabetes.

As expected, the Institute is sticking with its decision to reject Revolade (eltrombopag) as a treatment option for chronic immune (idiopathic) thrombocytopenic purpura (ITP) in adults who have had their spleen removed and failed to respond to other treatments, or as a second-line treatment for those in whom surgery is not advised.

Revolade is designed to boost platelet production by activating the thrombopoietin receptor in order to help reduce bleeding in patients but, at £22,000-£33,000 a year, the drug does not come cheap. Moreover, from the clinical evidence presented “it is not clear how much long term health benefits eltrombopag provides, compared with current alternative treatments available”, said Carole Longson, Health Technology Evaluation Centre Director at NICE.

The cost watchdog concluded that, while GSK’s drug was shown to raise platelet levels, its cost in relation to known and projected health benefits - £104,100 per quality adjusted life year (QALY) for splenectomised people, and £116,750 per QALY for non-splenectomised people - was way and above that what is normally considered a cost effective use of NHS resources.

Prolia through the door

On the a more positive note, NICE has published final guidance recommending the use of Amgen’s Prolia (denosumab) as an option for the prevention of primary and secondary osteoporotic fractures in postmenopausal women.

The Institute has agreed to fund the use of Prolia on the National Health Service but only for patients unable to take the oral bisphosphonates alendronate and either Procter & Gamble’s Actonel (risedronate) or etidronat, providing another treatment pathway for those at risk from osteoporotic fractures in whom standard therapy is not an option.

Prolia is a first-in-class monoclonal antibody that reduces osteoclast activity and thereby bone breakdown, and has the advantage over its rivals of being administered as a single subcutaneous injection twice yearly, which, as the Institute’s Appraisal Committee previously noted, could help to boost treatment compliance, a crucial factor in achieving the best treatment outcomes.

NICE approval of the drug for use by the NHS was based on data from the FREEDOM study, which clearly showed its fracture-reducing properties after the 36-month incidence of new radiographically-diagnosed vertebral fractures was found to be just 2.3% in women taking Prolia compared to 7.2% in those given a placebo.

In addition, Prolia’s relatively reasonable price tag – costing the NHS around £366 per patient per year - helped it fall well within the bounds of the Institute’s cost-effectiveness threshold, and thus secure its position within the health service.

New diabetes option

The news was also good for Novo Nordisk, after the cost watchdog published final guidance recommending Victoza (liraglutide; 1.2mg) as a treatment option on the NHS for certain patients with type 2 diabetes, making it the first incretin-based diabetes therapy to receive statutory funding direction.

Victoza is the world’s first once-daily human glucagon-like peptide-1 analogue, lowering blood glucose levels by stimulating the release of insulin only when glucose levels become too high, and it also has advantages over other diabetes therapies of appetite inhibition and a low risk of hypoglycaemia.

According to Novo, treatment with Victoza 1.2mg costs around £2.62 a day, and NICE has endorsed its use on the NHS as part of dual therapy regimens, i.e. in combination with metformin or a sulphonylurea, when the patient cannot take one of these drugs, or a thiazolidinedione or dipeptidyl peptidase-4 (DPP-4) inhibitor.

As part of triple therapy regimens, Victoza can be used in combination with metformin and a sulfonylurea, or metformin and a thiazolidinedione – but only when control of blood glucose is inadequate and the either patient has a Body Mass Index over 35kg/m2 or where weight loss would benefit other significant obesity-related co-morbidities, it said.

On the down side for Novo, the Institute rejected its 1.8mg formulation of the drug after concluding that the available evidence “does not suggest any significant additional benefit”.